The occurrence of leakages in systems which conduct medical fluids may regularly be problematic or even dangerous. Early detection of such leakages is thus of great importance.
One object of the present invention is to propose a method suited for the detection of leakages. Furthermore, an appropriate system as well as a medical-technical treatment apparatus are to be provided.
All advantages achievable by means of the method according to the present invention may undiminishedly also be achieved by means of the system and/or the medical-technical treatment apparatus.
The method according to the present invention is suited and provided for the detection of leakages in a system conducting a medical fluid, in particular upstream a shut-off device of the system, the system comprising at least the following components: at least one conveying device, a shut-off device and a section conducting the medical fluid, the section being arranged upstream the shut-off device. The conveying device serves for conveying the fluid through the section of the system. This is feasible at least in the direction towards the shut-off device. Furthermore, the conveying device may optionally be designed or embodied, respectively, or arranged or configured in addition for conveying in the opposite direction.
The method according to the present invention encompasses interrupting or reducing a fluid flow of the medical fluid through or out of the section during a first conveying effort of the conveying device. In order to interrupt or reduce, the shut-off device is adjusted or set, respectively, accordingly, e.g., closed. In this adjustment setting, a first conveying state is reached.
Further, the method according to the present invention encompasses reaching a second conveying state in the section by changing the conveying effort of the conveying device; the first conveying effort turns into a second conveying effort.
In a further step, the method according to the present invention encompasses emitting at least one signal by means of a signal emitting device—both in the first and the second conveying state—into the section of the system (measurable, e.g., within the section by means of a sensor present therein) and, where appropriate, through the section (measurable, e.g., as a transmittance on the side of the section opposite to the signal incidence side, or as a reflexion on the side of the section from which the signal was emitted).
The proportion of the emitted signal leaving the section again in the first conveying state (or penetrating into the section and being received within the section by the signal reception device) is thereby received by means of a signal reception device, the said proportion in the following being referred to as first proportion. Analogously, the proportion of the emitted signal leaving the section again in the second conveying state (or penetrating into the section and being received within the section by the signal reception device) is thereby received by means of the signal reception device, the said proportion in the following being referred to as second proportion.
Subsequently, in a further step of the method according to the present invention, based on an evaluation of the first proportion in relation to the second proportion, a conclusion may be drawn whether or not a leakage is present or has occurred, respectively.
The system according to the present invention comprises at least one controller suited and/or configured and/or provided for executing the method according to the present invention.
The medical-technical or medical treatment apparatus according to the present invention is provided for being connected, or is connected, with at least one system according to the present invention. In addition or instead, the treatment apparatus according to the present invention is, in certain embodiments, provided or intended for executing at least one method according to the present invention.
Embodiments according to the present invention may comprise some or all of the following features in any arbitrary combination.
In some embodiments according to the present invention, the emitted signal encompasses or consists of ultrasonic waves. In such a case, the signal emitting device emits ultrasonic waves and the signal receiving device detects the ultrasonic waves. The system according to the present invention may be designed or embodied correspondingly.
In certain embodiments according to the present invention, the signal emitting device and/or the signal receiving device are or comprise piezoelectric crystals.
In some embodiments according to the present invention, the emitted signal encompasses or consists of radiation. In such a case, the signal emitting device is a radiation source for emitting radiation and the signal receiving device is a radiation receptor for receiving or detecting radiation. The system according to the present invention may be designed or embodied accordingly.
In certain embodiments according to the present invention, the signal emitting device and the signal receiving device are one and the same device. Such a device thus serves both for emitting and receiving the respective signal. Such an embodiment or construction according to the present invention may be realized regardless of the type of signal to be transmitted and received. A common or combined embodiment or construction of a signal emitting device and signal receiving device in one single device being able to vary after switching or reversing the operating principle between emitting and receiving is—like an embodiment or construction of signal emitting device and signal receiving device as separate devices but present in one common housing—both when using ultrasound and when using other types of signals subject-matter of embodiments according to the present invention.
The present invention may, without, however, being limited hereto, advantageously be used for detecting leakages in an extracorporeal blood circuit and/or leaking connectors in or at a blood treatment apparatus such as, e.g., a dialyzer.
The term “system” as used herein in certain embodiments of the present invention refers to a (medical-)technical system—as opposed to a vascular system of a patient.
In certain embodiments of the present invention, the system comprises an arrangement of several components such as lines, tubes, channels, flow-promoting and/or flow-reducing elements, supply devices and/or drain devices, and the like, the arrangement being suited and/or provided or intended for conducting fluids. In certain embodiments, the system is designed or embodied, for instance, as a tube system such as an extracorporeal blood circuit without, however, being limited hereto.
The system is designed or embodied and/or provided or intended for receiving and/or conducting at least one medical fluid by means of a section contained in the system, such as an interior, e.g., a line interior, of the system.
The term “medical fluid” as used herein in certain embodiments according to the present invention refers to a fluid which is present or flowing extracorporeally and—e.g., during an extracorporeal blood treatment—is preferably to be treated.
The medical fluid in some embodiments according to the present invention is a liquid such as blood, dialysate, substituate, drug solutions, a gas, or a combination or mixture thereof.
The term “section” as used herein in certain embodiments according to the present invention refers to a part or portion or segment or section, respectively, of the system in which the leakage to be detected occurs or is to be ruled out.
The term “leakage” as used herein refers to a leak, an—unwanted—opening, a leakiness or a hole within the fluid-conducting system, in particular of the section through which the fluid conducted within the system may unwantedly escape from the system's interior to an exterior of the system. The occurrence of leakages may have arbitrary causes; these causes as such are irrelevant as regards the present invention.
The term “shut-off device” as used herein refers to a device or means, respectively, arranged at or on, respectively, or in the system, the device or means, respectively, being suited and/or provided or intended for reducing or interrupting or preventing, respectively, a streaming or a flow of the medical fluid through at least one section of the system.
In certain embodiments of the present invention, the shut-off device is intended or provided for interrupting or reducing an escaping or flowing of the fluid from or out of the section into an area downstream the shut-off device.
The term “downstream” in certain embodiments according to the present invention is to be understood as a streaming direction within the section, which when executing the method as described herein leads away from the conveying device.
The shut-off device may, without being limited hereto, be a clamp, such as an arterial clamp or a venous clamp of an extracorporeal blood circuit, an inductor or choke, respectively, a valve, a shut-off valve, and the like, or may comprise one or more such elements. It may be one piece or comprise several parts. The shut-off or barrier effect of the shut-off device may be a result of the interaction of several, i.e., multiple, shut-off components, or, however, solely of one single shut-off component.
The term “conveying device” as used herein in certain embodiments according to the present invention refers to a device or means, respectively, suited and/or provided or intended for conveying the medical fluid within an interior of the system or a section thereof, respectively, or through or along the interior or the section. Conveying the medical fluid may be effected indirectly or directly.
The concrete design or arrangement or construction, respectively, of the conveying device is not limited according to the present invention. Non-limiting examples include non-occluding pumps such as a centrifugal pump, and the like.
The term “conveying effort” as used herein in certain embodiments of the present invention, in certain embodiments according to the present invention relates to an output or effort or performance, respectively, or work performed by the conveying device for conveying the medical fluid. This may be measured by means of, e.g., a voltage metering or a current measurement at the inlet of the conveying device.
In some embodiments according to the present invention, the conveying effort corresponds to a conveying output or performance, respectively, (e.g., in milliliters per minute, ml/min) which would be conveyed within the section by means of the conveying device in case the shut-off device being open.
In some embodiments according to the present invention, the conveying effort corresponds to a characteristic of the conveying device variable during the use of the conveying device. This includes a set or targeted or intended or conducted number of revolutions per minute of the conveying device.
A conveying effort in certain embodiments of the present invention refers to a state of the conveying device during conveying the medical fluid, in particular a state for which the conveying device was adjusted for conveying the medical fluid, e.g., by setting or specifying, respectively, certain parameters such as a conveying pressure, a conveying output or performance, a conveying speed, and the like.
“Changing a conveying effort”, e.g., changing the first conveying effort to become a second conveying effort, may be achieved by changing at least one of the parameters set or adjusted, respectively, or settable or adjustable, respectively, for a conveying state, such as, for example, by changing the rotational speed.
Thereby, the—first and/or second—conveying effort performed by the conveying device may be constant or not constant. Preferably, the first and/or second conveying effort performed by the conveying device is substantially or completely constant.
The terms first and second “conveying state” in certain embodiments according to the present invention describe the state appearing in relation to a first and second flow rate downstream the shut-off device appearing in the section as a result of both the conveying effort of the conveying device and the barrier effect of the shut-off device.
The first conveying state and the second conveying state may be the same or different. At least one of the two conveying states may be zero.
Thus, a first conveying state may be zero, expressed, e.g., by a flow of 0 ml/min, measured or at least measurable downstream the shut-off device. This may be a result of a complete shut-off of a flow across the shut-off device. Likewise, a second conveying state may be zero which may, e.g., be a result of a complete stop of the conveying device. However, the present invention is not limited to measurements or examinations or analyses, respectively, during complete shut-off by means of the shut-off device or complete interruption of the fluid flow by stopping the conveying device, or feasible only in this way, as is recognizable for the skilled person. Rather, it is also possible to achieve the advantages of the method according to the present invention with the shut-off device being only partly shut or closed, respectively, and accordingly only partial throttling of the conveying device. These embodiments are encompassed by the present invention as well. This is expressed by the use of the term “conveying state” as described above.
In certain embodiments, the present invention encompasses that initially a first conveying state is considered, and subsequently the second conveying state. However, the present invention is not limited hereto. For instance, the order of the examination or measurement is arbitrary as can also be taken from FIGS. 2 to 5. For example, in some embodiments initially the conveying device may be stopped or throttled and only after that the shut-off device may be shut off or throttled, or vice versa.
In certain embodiments of the present invention, the emitted radiation—wherein radiation here is to be understood as an example for a signal as used herein—is or encompasses electromagnetic radiation such as visible light.
In certain embodiments of the present invention, the emitted radiation is or encompasses infrared radiation, e.g., from a narrowband infrared light source. A peak wavelength of the infrared radiation is preferably approximately or exactly 805 nm.
The term “radiation receptor” as used herein in certain embodiments of the present invention refers to a device or a means or a sensor, respectively, which is suited and/or provided or intended and/or designed or embodied for receiving and/or detecting the radiation emitted out of the section of the system.
Non-limiting examples of radiation receptors include optical detectors such as a photodiode, a photoconductive cell or a photo transistor, and the like.
The radiation receptor may, like the radiation source, be designed or embodied in one piece or consisting of or comprising several parts and/or may be designed or embodied by means of one or more component(s) for receiving and/or emitting radiation. In some embodiments of the present invention, the radiation receptor is provided or intended and designed or embodied as an individual and/or independent component. In some embodiments of the present invention, the radiation receptor is provided in one shared or common physical arrangement such as a shared or common housing together with the radiation source.
The term “signal receiving device” as used herein goes beyond the term “radiation receptor” as described above as regards content. A signal receiving device may be a radiation receptor; however, it is not limited to receiving radiation. Instead of—or in addition to—radiation, another signal, e.g., an ultrasonic signal, may be received. The same relation applies to the terms “radiation source” and “signal emitting device”.
The term “receiving” a proportion of the emitted signal, e.g., of the emitted radiation as used herein in certain embodiments of the present invention refers to a targeted reception or detection of the signal emitted out of the section of the system, e.g., the emitted radiation.
The “proportion of the emitted signal” may be a proportion of a signal, e.g., radiation, which leaves the section—e.g., by reflexion, transmittance, scattering etc.—or a proportion of a signal, e.g., radiation, which has penetrated the section and was measured therein.
The term “proportion” as used herein in certain embodiments of the present invention refers to a part or portion, respectively, e.g., a fractional part or subset, to which the received signal, e.g., the received radiation, amounts in relation to the originally emitted signal.
The proportion of the emitted signal, e.g., radiation, which is received again after emission, in some embodiments according to the present invention is a fractional part of an intensity (measured, e.g., as amplitude of a signal, as counts, as counts per time unit, as electric potential after corresponding conversion, electric current, frequency, etc.).
Counts may thereby, without being limited hereto, be obtained as follows: When using a signal receiving device which is designed or embodied as a photo receiver which operates as a light-to-frequency-converter, the sensor used delivers a frequency proportional to the received light intensity. For the evaluation, e.g., the edges of the signal are counted over a certain time unit; each edge is thereby classified as a count.
In some embodiments of the present invention, this proportion of the emitted signal or of the emitted radiation leaving the system or the section of the system, respectively, is exclusively or also a reflected signal. In some embodiments of the present invention, the proportion of the emitted signal or of the emitted radiation leaving the system or the section of the system, respectively, is exclusively or also a transmitted signal. In certain embodiments of the present invention, the proportion of the emitted signal, e.g., of the emitted radiation, leaving the system or the section of the system, respectively, is an exclusively or also scattered, e.g., sidewards or laterally scattered, signal, e.g., radiation.
For drawing a conclusion whether a leakage is present, by means of an evaluation of the first proportion in relation to the second proportion, in certain embodiments according to the present invention a comparison of the first proportion and the second proportion, or of the amounts or levels or extents or the characteristics, respectively, is intended or provided.
The comparison of the first proportion and the second proportion in certain embodiments of the present invention is made by comparing a first average value of a first received signal received as a first proportion over a certain first time period to a second average value of a second received signal received as a second proportion over a certain second time period.
In some embodiments of the present invention, the comparison is made by subtracting the first proportion or the average value of the first proportion from the second proportion or the average value of the second proportion in order to obtain a difference or a difference value.
In some embodiments, the comparison is made by comparing signal spectra or radiation spectra of the first and the second proportion of the received signal or of the received radiation. For example, the absolute values of signal maxima or radiation maxima and/or signal minima or radiation minima of the recorded signal spectra or radiation spectra may be compared.
In some embodiments of the present invention, the comparison is made by establishing a relation between the first proportion or the first average value thereof and the second proportion or the second average value thereof.
In certain embodiments of the present invention, drawing a conclusion whether a leakage is present encompasses or consists of a comparison with a threshold value. Thereby, a difference, a relation or a value derived in any other way may be compared with the threshold value. The difference or the relation may in particular be determined as described above.
The threshold value may in particular be a predetermined threshold value or reference value such as, for example, a threshold value detected, calculated, estimated, or the like, in a system or a section, respectively, without leakage.
In certain embodiments of the present invention, the first and/or the second proportion is or reflects a percentage signal intensity or radiation intensity (I).
In certain embodiments of the present invention, the signal reception device, in particular when being designed or embodied as radiation receptor, is used for detecting an optical density or a change hereof. The latter may serve for detecting a leakage but is, however, not mandatorily necessary.
In such embodiments, it may, for example, advantageously be possible to differentiate between the presence of blood or water in an extracorporeal blood circuit.
In order to execute the method according to the present invention, in certain embodiments according to the present invention a fluid flow of the medical fluid through the section of the system in the first conveying state is stopped by means of the shut-off device. The flow may be stopped, i.e., be set to zero. In other embodiments according to the present invention, the fluid flow is only appropriately reduced or throttled by means of the shut-off device, however, not completely stopped.
In such a case, the conveying device may or may not continue conveying.
In certain embodiments of the method according to the present invention, it is intended to stop the conveying device in the second conveying state. In other embodiments according to the present invention, the conveying device is only throttled, however, not completely stopped.
In certain embodiments of the present invention, it is intended to issue an alarm if executing the method according to the present invention would lead to the result or the assumption that a leakage is present in the fluid-conducting system. Depending on the wish or request and/or the demand or requirement, respectively, the alarm may be an optical alarm, an acoustic alarm or any arbitrarily suited alarm as well as a combination of different alarms.
All, a few or some steps of a method according to the present invention as described exemplarily and in a non-limiting way with regard to the appended drawing may be performed automatically. For each of the procedural steps as described in relation to the method according to the present invention, the apparatuses according to the present invention may comprise corresponding devices for the implementation thereof.
In certain embodiments of the present invention, the system according to the present invention comprises at least one treatment cassette comprising at least one section conducting a medical fluid, a conveying device for conveying the fluid through the section as well as a shut-off device for interrupting or reducing the fluid flow through the section.
The term “treatment cassette” as used herein refers to a functional device that is intended or provided and/or is or will be used for performing a medical treatment, e.g., an extracorporeal blood treatment.
Examples of treatment cassettes include a blood cassette, e.g., in form of a cast part or an injection-molded part, irrespective of whether or not the blood cassette is designed or embodied as a one-way article or a disposable.
In certain embodiments of the system according to the present invention, at least the conveying device is part of the treatment cassette.
The system according to the present invention in certain embodiments comprises a radiation source for emitting radiation as a signal emitting device.
The radiation source in certain embodiments is designed or embodied for emitting electromagnetic radiation, in particular infrared light.
The signal emitting device in some embodiments is embodied or designed for emitting ultrasonic waves.
In certain embodiments according to the present invention, the system comprises a signal receiving device configured and/or provided or intended for receiving a proportion of the emitted signal and a controller for executing the method according to the present invention.
In certain embodiments, the signal receiving device is configured and/or provided or intended and/or designed or embodied for detecting reflected and/or transmitted and/or scattered signals.
In certain embodiments according to the present invention, the signal receiving device is designed or embodied as a device for receiving ultrasonic waves.
In some embodiments according to the present invention, the signal receiving device is designed or embodied as a device for receiving radiation.
The system according to the present invention in certain embodiments further comprises at least one comparing device for comparing the first proportion received in the first conveying state to the second proportion of the emitted signal, e.g., of the emitted radiation and/or of the ultrasonic waves, received in the second conveying state.
In certain embodiments of the system according to the present invention, further a decision device configured and/or provided or intended for drawing a conclusion whether a leakage is present in or within, respectively, or at or on, respectively, the system by means of an evaluation of the first proportion in relation to the second proportion.
In certain embodiments, the system further comprises at least one alarming device configured for issuing an alarm when a leakage is detected.
In some embodiments according to the present invention no gas-pump and/or no flow-meter for measuring the gas flow are used or provided, and/or no gas flow is measured.
In certain embodiments according to the present invention no negative pressure is applied during the execution of the method according to the present invention. Accordingly, in some embodiments according to the present invention no devices for applying negative pressure are provided and/or are used during the execution of method according to the present invention.
In some embodiments according to the present invention no result in absolute numbers is received or established.
In certain embodiments according to the present invention no flowrate is measured or determined.
The object according to the present invention is further also solved by a digital storage medium, a computer program product and a computer program.
A digital storage medium, in particular in the form of a disk, CD or DVD, having electrically readable control signals, may interact with a programmable computer system such that the execution of the technical steps of a method according to the present invention is prompted.
Thereby, all, a few or some of the technically executed steps of the method according to the present invention may be prompted.
A computer program product comprises a program code stored on a machine-readable medium for prompting the execution of the technical steps of the method according to the present invention when executing the computer program product on a computer.
The term “machine-readable medium” as used herein in certain embodiments of the present invention refers to a medium containing data or information which is interpretable by software and/or hardware. The medium may be a data medium such as a disk, a CD, DVD, a USB flash-drive, a flashcard, an SD card, and the like.
A computer program comprises a program code for prompting the execution of the technical steps of a method according to the present invention when executing the computer program on a computer.
It applies also to the computer program product and the computer program that all, a few or some of the technically performed steps of the method according to the present invention are prompted.
Certain embodiments according to the present invention comprise one or more of the following advantages.
The present invention provides a method and apparatuses by means of which in some embodiments according to the present invention the detection of leakages—irrespective of which cause—in fluid-conducting systems is advantageously and in a simple manner possible.
As the intensity of the detected signal, e.g., of the detected radiation, of the flowing blood differs from that of non-flowing or still-standing blood, it may, in certain embodiments of the present invention, for example, in an advantageously simple manner be possible to observe or optically detect, respectively, a change in the distribution of blood cells within the section of the system, and, due to the change, easily deduce a leakage in the blood-conducting system.
Pressure-holding or maintenance tests which are usually established for checking the leak tightness of fluid-conducting systems comprising occluding pumps such as roller pumps, hose pumps, displacement pumps etc., are, due to the underlying principle, not feasible for detecting leakages with constant pressure sources, i.e., non-occluding pumps such as centrifugal pumps, as the pressure will be constant also with small leakages being present. For such systems with non-occluding pumps, the present invention advantageously offers a simple and little elaborate possibility of detecting leakages nevertheless.
The use of an optical sensor may hereby in particular be of advantage for achieving greater accuracy also in case of small leakages, which is not possible by, e.g., flow sensors.
Additionally, the optical sensor used according to the present invention is an advantageously simple sensor which may at the same time contribute to reducing the constructional and/or financial effort associated with the system.
Furthermore, in certain embodiments of the present invention it may advantageously be possible to conduct further measurements such as, for example, a differentiation between blood and water and/or air or measurements of hematocrit hemoglobin concentrations, respectively, and the like while using one and the same sensor which may also be used for executing the method according to the present invention.